We're currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
1. Drive laboratory operations within the new laboratory facility which will include oversight of equipment qualification (PQ), documentation generation and SME review of SOP's, Work instructions as well as contributing to lab and process establishment.
2. Review and/or lead, trending and reporting of laboratory data, to support batch release, maintain oversight of review metrics, to collate and analyse end of quarter and year reports for all raw data generated.
3. Maintaining and release of laboratory stock, ordering laboratory consumables where required.
4. Active participation in functional meetings, leading of departmental and cross-functional meetings where required.
5. Participation in internal and external audit and inspection activities and ensure permanent inspection readiness.
6. Support and drive site safety & ways of working culture demonstrating respect and appreciation for diverse populations.
7. Perform supporting GMP activities & troubleshooting for general lab operations, EM, Facility testing as required, and execute in-process and drug substance analysis studies & lead/ participate in laboratory projects.
8. Support introduction of novel, innovative solutions, collaborating with the global Microbiology Center of Expertise and participating in lean lab methodologies.
9. Ability to organise and establish testing schedules and adhere to deadlines.
10. Build team effectiveness skills, learn to promote team success through own actions and by
11. Be flexible to support changing business needs, (e.g. Infrequent out of hours testing support for exceptional circumstances).
12. Be able to share and communicate that knowledge through training other analysts & maintain timely training completion
Education & Experience
13. A degree qualification in a relevant field(Biological Sciences/ Engineering), preferable for background in microbiology, AnAdvanced Degree (e.g., MSc) qualificationis desirable.
14. A 3+ years experience working in a relevant industry field.
15. Technical Knowledge with Biologics drug substance manufacturing and microbiological testing techniques.